Mechanical Failure of the Stryker T2 Alpha Retrograde Femoral Nail.

OBJECTIVES

To evaluate mechanical failure rates of retrograde femoral nails in the treatment of distal femur fractures.

DESIGN

Retrospective chart review.

SETTING

Urban Academic Level 1 Trauma Center.

PATIENT SELECTION CRITERIA

Included were adult patients who sustained a distal femur fracture (Arbeitsgemeinschaft fur Osteosynthesefragen Foundation/Orthopaedic Trauma Association 33) who were treated with a retrograde intramedullary nail from August 2021 through September 2022.

OUTCOME MEASURES AND COMPARISONS

The primary outcome was the rate of mechanical failure of the intramedullary nail defined as deformation and/or breakage of the intramedullary nail. The rate of mechanical failure was compared among retrograde femoral nails used at the same institution during the same time period.

RESULTS

One hundred and twenty distal femur fractures were identified (77 native distal femur, 43 periprosthetic) that were treated with a retrograde intramedullary nail. Average patient age was 67 years (SD 15.1, range 18-96 years). Eighty-three (69.2%) patients were women. Four mechanical nail failures (deformation and/or breakage of the intramedullary nail) were observed within 6 months of surgery, 2 in patients with native distal femur fractures and 2 in patients with periprosthetic distal femur fractures. All failures occurred among 49 fractures treated with a newly released retrograde femoral nail, the T2 Alpha Retrograde Femoral Nail (Stryker, Mahwah, NJ). This represents an 8.2% mechanical failure rate of distal femur fractures treated with this new nail compared with no failures observed with any other nail ( P = 0.03).

CONCLUSIONS

Mechanical nail failures, within 6 months of surgery for distal femur fracture, of a new retrograde femoral nail were observed to be higher than seen with other nails. Further evaluation is needed to determine whether this experience represents factors related to patient, injury, or surgical characteristics, an anomaly, or a safety signal.

LEVEL OF EVIDENCE

Prognostic Level III. See instructions for authors for a complete description of levels of evidence.